Rise and shine, everyone, yet another busy day is on the way. And it is likely to be cold, too. To keep warm and focused, we are, as always, quaffing a few cups of delicious stimulation. And you are, of course, invited to join us. Meanwhile, we are thumbing through our to-do list as the priorities pile up. You know, meetings and deadlines and stuff like that. Somehow, we have a feeling that you can relate. So time to peruse the items listed below and get on with it. Hope you have a swell day and we look forward to hearing from you…

Ranbaxy Laboratories lost a bid for a temporary court order to block the FDA from approving rival generic versions of the Nexium heartburn pill and the Valcyte antiviral drug, Reuters reports. Ranbaxy sought the order in a lawsuit the drug maker filed earlier this week against the FDA after the agency rescinded of tentative approval to make and sell its own generic versions of the drugs. The lawsuit was filed shortly after the FDA told Ranbaxy it had made an error in granting tentative approval to launch the drugs, citing quality lapses at Ranbaxy plants in India.

The British government has launched a review to speed the path to market for new drugs and medical devices in an attempt to improve patient care and make the country a more attractive place for investment in life sciences, according to Reuters. The moves comes after drug makers have complained that the state-run National Health Service (NHS) is too slow to adopt new treatments. The review aims to tackle the issue by studying innovative models for drug development.

The alliance between Michael Pearson, the Valeant Pharmaceuticals ceo, and Bill Ackman, who heads the Pershing Square Capital Management fund, was an unorthodox match and, not surprisingly, they did not always see eye-to-eye in deciding how to pursue Allergan, The Wall Street Journal writes. For instance, Pearson hoped the pairing would buoy Valeant shares and rebut the bears who questioned its growth strategy. And Ackman wanted to proceed faster with a tender offer than the Valeant team.

Missouri Attorney General Chris Koster will now ban donations from any company targeted for investigation after reports his office may have given preferential treatment to campaign contributors and lobbyists for Pfizer and other companies, The New York Times says. His office settled a case with the drug maker for far less than other states of a similar size had received, after taking tens of thousands of dollars in donations from Pfizer and the law firm representing the company, Dickstein Shapiro of Washington.

Deficiencies related to quality systems are the most prevalent issue cited from inspections by the U.K.’s Medicines and Healthcare Products Regulatory Agency, writes In-Pharmatechnologist, citing an MHRA report on 2013 inspections.

Rep. Frank Pallone (D-N.J.) won a vote to replace Rep. Henry Waxman (D-CA.) as the ranking Democrat of the House Energy & Commerce Committee, which has oversight authority for the FDA, NIH, CMS and the U.S. Patent and Trademark Office, BioCentury tells us.

Sanofi and Regeneron Pharmaceticals say the FDA designated their dupilumab drug as a breakthrough therapy for treating a chronic form of eczema and granted the product a fast-track development and review process, Reuters writes.

Johnson & Johnson filed an application with the FDA to market a three-month injectable formulation of Invega Sustenna for treating schizophrenia, according to Pharma Times.

The U.K.’s National Institute for Health and Care Excellence wants Novartis provide more data on Xolair before it can recommend the asthma drug to treatment chronic hives in kids, Pharmafile writes.

The California Supreme Court agreed to review an appeal by Bristol-Myers Squibb on whether 575 people who are not state residents can join a lawsuit claiming they were harmed by its Plavix bloodthinner, according to San Francisco Gate.

For the second time this year, a bill has been introduced in Congress to streamline the process used by the U.S. Drug Enforcement Agency to place prescription drugs that are controlled substances on a list of medicines for which distribution is restricted.

The goal is to get these medicines to the market faster, since controlled substances must first be placed on the DEA list before they can reach pharmacy shelves. Drug makers have complained that the process can be lengthy and hamper their ability to take advantage of an important five-year marketing exclusivity period following FDA approval in which generic competition can be kept at bay.

The move comes only a few weeks after Eisai, the big Japanese drug maker, filed a lawsuit against the FDA. The drug maker claimed in its lawsuit that it was “unfairly” penalized after the agency approved two drugs – a diet pill and an epilepsy treatment – both of which are controlled substances. But the drug maker charges it was prevented from marketing the medicines on a timely basis because both agencies bungled the process.

In its lawsuit, Eisai claimed the FDA mishandled the process for notifying the DEA of the approvals and then DEA scheduling was tardy and wasted valuable marketing time. Eisai wants the courts to force the FDA to extend the marketing period for the two drugs, but the case has also attracted attention from members of Congress over the larger issue of making drugs available to patients as soon as possible.

“This bill takes several important steps towards making the approval process for important new therapies more efficient, transparent, and consistent, while also ensuring patients have access to medications in a timelier manner,” says U.S. Senator Orrin Hatch (R-Utah), in a statement.

The bill would require the DEA to list a drug within 45 days of receiving an application for a scheduling recommendation from the U.S. Department of Health and Human Services. Currently, there are no regulations that require the DEA to list a drug by a certain time, which has irked both drug makers and patient groups.

Not surprisingly, the bill was greeted warmly by patient groups. “When new medicines are developed and approved by FDA, it is vital to their health and well-being that they have access to physician directed care that could dramatically improve and possibly save their lives. Time is critical,”says Angela Ostrom, a vice president of public policy & advocacy at the Epilepsy Foundation, in a statement.

This is the second such bill introduced in recent months to speed the DEA listing of FDA-approved medicines that are also controlled substances. Last March, two members of the House – Frank Pallone (D – N.J.) and Joe Pitts (R-Pa.) introduced a bill in the House, just a few weeks before the FDA denied a Citizen’s Petition that Eisai had filed in hopes the agency would extend the marketing period for its drugs.

A DEA spokesman notes the agency is trying to work more closely with the FDA and, as an example, says some scientific information is being provided prior to FDA marketing approval. As a result, this allows the DEA to move more quickly to list a controlled substance once a drug is approved by the FDA.

We should note that during the 2014 election cycle, Pallone received $2,000 from an Eisai political action committee, which also contributed $1,500 to Pitts, as well as $2,500 to Sheldon Whitehouse (D-R.I.), who co-sponsored the Senate bill, according to the Center for Responsive Politics (see this).

Eisai also contributed $3,500 to OrrinPAC, a Hatch political action committee, which was one of the largest entities to receive a donation, according to the Center for Responsive Politics. And Eisai contributed between $100,000 and $250,000 to the Epilepsy Foundation in 2013, according to its website, which listed the drug maker as a corporate partner.

We asked Eisai and the lawmakers for comment and will update you accordingly.